ML20033C264
| ML20033C264 | |
| Person / Time | |
|---|---|
| Site: | 07100467 |
| Issue date: | 10/15/1981 |
| From: | Clame A PORTABLE ATOMIC X-RAY CO. |
| To: | |
| References | |
| 19905, NUDOCS 8112020961 | |
| Download: ML20033C264 (2) | |
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ORGANIZATION e
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n The final responsibility for the QA Program for Part 71 req'b(r g ts rests'Mith Portable Atomic X-Ray Co.,
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Design and fabrication shall not be conducted under this QA Program. The Radiation Safety Officer is designated the responsible inidvidual for the part 71 quality assurance requirements.
2 The Radiation Safety Officer is responsible for overall administration of the program, training and certification, document control and auditing.
The Radiographers are responsible for handling, storing, shipping, inspectier test and operating status and record keeping.
2.
QUALITY ASSURANCE PROGRAM The management of Portable Atomic X-Ray Co., Inc., establishes and implements this )
QA Program.
Training, prior to engagement, for all QA functions is required according to written procedures.
QA Program revisions will be made according to written procedures with management approval.
The QA Program will ensure that all defined QA Procedures, engineering procedures and specific provisions of the package design approval are satisfied. The QA Program will emphasize control of the characteristics of the package which are critical to safety.
The Radiation Safety Of ficer shall assure that all radioactive material shipping packages are designed and manufactured under a QA program approved by Nuclear Regulatory Commission for all packages designed or fabricated after January 1, 1979. This require-ment can be satisfied by receiving a certification to this effect from the manufacturer.
3.
DOCUMEN". CONTROL All documents related to a specific shipping package will be controlled through the use of written procedures. All dott. ment changes will be performed according to written procedures approved by management.
The Radiation Safety Of ficer shall ensure that all QA functions are conducted in accordance with the latest applicable changes to these documents.
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- Quality Assurance Program 4
HANDLING, STORAGE AND SHIPPING s
j Written safety procedures concerning the handling, storage and shipping of packages for certain special form radioactive material will be followed.
Shipments will not be made unless all tests, certifications, acceptances and final inspections have been completed. Work instructions will be provided for handling, storage and shipping operations.
Radiography personnel shall perform the critical handling, storage and shipping operations.
5.
INSPECTION, TEST AND OPERATING STATUS Inspection, test and operating status of packages for certain special form radioactive material will be indicated and controlled by written procedures.
Status will be indicated by tag, label, marking or log entry.
Status of nonconforming parts or packages will be positively maintained by written procedures.
Radiography personnel shall perform the regulatory required inspections and test in accordance with written procedures.
The Radiation Safety Offic ?r shall ensure that these functions are performed.
t 6.
QUALI"Y W;SURANCE RECORDS Records of package approvals (including references and drawings), procurement, inspections, tests, operating logs, audit results, personnel training and qualifications and records of shipments will be amintained.
Descriptions of equipment and written procedures will also be maintained.
a) The records will be maintained in accordance with a written procedure.
b) The records will be identified and retrievable.
c) The Radiation Safety Officer will maintain a list of the records and their storage location.
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7.
AUDITS Established schedule of audits of the QA Program will be performed using written check lists. Results of audits will be maintained.
Audit reports will be evaluated and de fi c i ent areas corrected. The audits will be dependent of the safety significance of the activity being audited, but each activity will be audited at least once a year.
Audit reports will be maintained as part of the quality assurance records.
Members of the audit team shall have no responsibility in the activity being audited.
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Alvin M.'Calame, Ridiation ety Officer Portable Atomic X-Ray Co.,
Inc.
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